UAB Center of Research Translation (CORT) Project 2: The Effects of Urate Lowing Therapy (ULT) in Inflammation, Endothelial Function, and Blood Pressure

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Alabama at Birmingham
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT02038179
First received: December 20, 2013
Last updated: August 10, 2014
Last verified: July 2014
  Purpose

We propose a novel intervention for reducing BP that could have a preferential impact in patients with hyperuricemia and gout. There is a great need for new anti-hypertensives, particularly among those with gout. The proposed study is novel in its plans to investigate the physiologic mechanisms through which urate contributes to vascular disease and by which ULT may contribute to BP reduction. Also innovative, we will: 1) determine to what extent the described benefit of lowering serum urate extends beyond the adolescent population previously studied into young adults, 2) test whether a urate-lowering approach will benefit individuals that do not yet meet the current definition of hyperuricemia and do not have gout, and 3) begin to explore potential mechanisms for the higher prevalence of hypertension among African-Americans. If successful, this work could translate to the standard of clinical care and to health care recommendations for the population as a whole.


Condition Intervention Phase
Pre-hypertension
JNC 7 Stage I Hypertension
Drug: Allopurinol
Drug: Placebo
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: UAB Center of Research Translation (CORT) Project 2: The Effects of Urate Lowing Therapy (ULT) in Inflammation, Endothelial Function, and Blood Pressure

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Serum urate level [ Time Frame: Baseline to Visit 5 (14 weeks) ] [ Designated as safety issue: No ]
    Serum urate level is measured and compared to previous measures.

  • Serum urate level [ Time Frame: Baseline to Visit 3 (6 weeks) ] [ Designated as safety issue: No ]
    Serum urate level is measured and will be compared to baseline

  • Serum urate level [ Time Frame: Baseline to Visit 4 (10 weeks) ] [ Designated as safety issue: No ]
    Serum urate level is measured and will be compared to baseline.

  • Serum urate level [ Time Frame: Baseline (Visit 1) ] [ Designated as safety issue: No ]
    Baseline serum urate level is measured.

  • Serum urate level [ Time Frame: Baseline toVisit 2 (2 weeks) ] [ Designated as safety issue: No ]
    Serum urate level is measured and compared to baseline

  • Endothelial function as measured by flow mediated dilation (FMD) [ Time Frame: Baseline (Visit 2) to Visit 5 (12 weeks) ] [ Designated as safety issue: No ]
    Endothelial function is measured and compared to previous measures.

  • Endothelial function as measured by flow mediated dilation (FMD) [ Time Frame: Baseline (Visit 2) to Visit 4 (8 weeks) ] [ Designated as safety issue: No ]
    Endothelial function is measured and compared to previous measures.

  • Endothelial function as measured by flow mediated dilation (FMD) [ Time Frame: Baseline (Visit 2) to Visit 3 (4 weeks) ] [ Designated as safety issue: No ]
    Endothelial function is measured and compared to previous measures.

  • Endothelial function as measured by flow mediated dilation (FMD) [ Time Frame: Visit 2 (baseline) ] [ Designated as safety issue: No ]
    Endothelial function is measured and baseline is established.


Estimated Enrollment: 112
Study Start Date: July 2014
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Allopurinol arm
Participants will be asked to take 4 weeks of allopurinol or placebo, then will crossover to the other drug (after 4 week washout period) and take either allopurinol or placebo for an additional 4 weeks.
Drug: Allopurinol
The subjects will be randomized to receive allopurinol as ULT, at a daily dose of 300 mg once daily by mouth or placebo. Participants will be asked to take 4 weeks of allopurinol or placebo, then will crossover to the other drug (after 4 week washout period) and take either allopurinol or placebo for an additional 4 weeks.
Placebo Comparator: Placebo Arm
Participants will be asked to take 4 weeks of allopurinol or placebo, then will crossover to the other drug (after 4 week washout period) and take either allopurinol or placebo for an additional 4 weeks.
Drug: Placebo
The subjects will be randomized to receive allopurinol as ULT, at a daily dose of 300 mg once daily by mouth or placebo. Participants will be asked to take 4 weeks of allopurinol or placebo, then will crossover to the other drug (after 4 week washout period) and take either allopurinol or placebo for an additional 4 weeks.

  Eligibility

Ages Eligible for Study:   19 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pre-hypertension or stage I hypertension, defined as the following after the mean of two clinic measurements:
  • Systolic blood pressure (SBP) ≥ 120 and <160 or;
  • Diastolic blood pressure (DBP) ≥ 80 and < 100
  • Serum urate ≥ 5.0 mg/dL for men or ≥ 4.0 mg/dL for women
  • Age 19-35

Exclusion Criteria:

  • Any current pharmacological treatment for hypertension, including diuretics
  • Estimated glomerular filtration rate < 60 mL/min/1.73m2
  • Current use of any urate-lowering therapy or statins
  • Prior diagnosis of gout or past use of urate-lowering therapy for gout
  • Prior diagnosis of diabetes
  • Pregnancy, or recent delivery or last trimester pregnancy loss more recent than 3 months
  • Active smokers
  • Immune-suppressed individuals including transplant recipients or current use of azathioprine.
  • Leucopenia with absolute white cell count < 3000 /mL, anemia with hemoglobin < 12 g/dL, or thrombocytopenia with platelet count < 150,000/mL
  • Individuals of Han Chinese or Thai descent with HLAB5801 genetic phenotype
  • Serious medical condition that at investigator's judgment precludes utilization of a fixed dose of allopurinol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02038179

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Jeff Foster, MPH    205-996-6086    fosterau@uab.edu   
Principal Investigator: Kenneth G Saag, MD, MsC         
Sponsors and Collaborators
University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02038179     History of Changes
Other Study ID Numbers: F130408004, P50AR060772
Study First Received: December 20, 2013
Last Updated: August 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Alabama at Birmingham:
Pre-hypertension
JNC 7 stage I hypertension

Additional relevant MeSH terms:
Prehypertension
Hypertension
Inflammation
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Allopurinol
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 20, 2014